On October 20, 2025 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, reported the presentation of updated data from 16 patients with metastatic uveal melanoma treated with anzu-cel PRAME cell therapy.

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The uveal melanoma data from the ongoing Phase 1b trial will be presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 during the Presidential Symposium III by Sapna Patel, M.D., Professor of Medicine, University of Colorado Cancer Center. The slides are accessible in the ‘Events & Presentations’ section of the Investors & Media section of the Company’s website.

"Patients with metastatic uveal melanoma face a poor prognosis and represent a population in need of better outcomes, given the limited options currently available," said Sapna Patel, M.D. "I believe the results with anzu-cel presented today signal a much-needed breakthrough for patients with metastatic uveal melanoma. These findings highlight the potential of anzu-cel to redefine the treatment paradigm for uveal melanoma and bring new hope to patients who urgently need more effective options."

"Our goal is to leverage every opportunity to bring innovative PRAME therapies to patients with limited treatment options," said Cedrik Britten, M.D., Chief Medical Officer at Immatics. "The continued strong clinical data presented today reinforce our conviction in maximizing the potential of our PRAME cell therapy, anzu-cel, and expanding its development into metastatic uveal melanoma, a rare cancer with very high unmet medical need. We are excited to further execute on our PRAME franchise and bring meaningful progress to patients in need."

Presidential Symposium III Presentation Summary – Anzu-cel Phase 1b Trial

Patient Population: Difficult-to-treat patient population with metastatic uveal melanoma

As of September 24, 2025, 16 patients with metastatic uveal melanoma were administered a one-time infusion of anzu-cel at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR T cells) as part of the anzu-cel Phase 1b dose expansion. Patients received a median infused TCR T-cell dose of ~4 billion (range 1.62 – 8.43 billion TCR T cells) and had a median of 2 lines of prior systemic treatments. Patients had a median target lesion sum of a diameter of 103 mm (ranging from 31 to 210 mm), and 81% of patients had liver and extrahepatic metastasis.

Anti-tumor Activity and Durability: Continued strong anti-tumor activity and durability of anzu-cel PRAME cell therapy

Updated data of a one-time infusion of anzu-cel PRAME cell therapy demonstrated promising benefit in a difficult-to-treat population with limited effective treatment options:

Confirmed objective response rate (cORR) of 67% (10/151)
Disease control rate (DCR) of 88% (14/16)
Median duration of response (mDOR) of 11 months (min 4.4, max 31.6 months)
Median progression-free survival (mPFS) of 8.5 months (min 1.4, max 32.9) at a mFU of 10.4 months. The PFS rate was 69% at six months and 39% at 12 months
Median overall survival (mOS) not reached (min 4.3+, max 34.2+ months) at a mFU of 14.3 months. The OS rate was 71% at 12 months

Anti-tumor activity was observed in liver and extrahepatic metastases, including lung, lymph node, abdomen/peritoneum and others. 14/16 patients had target lesions in the liver and treatment with anzu-cel led to a median shrinkage in liver target lesion size of 49.6%.

Notably, 11 out of the 16 patients received a TCR bispecific (ten gp-100-targeting, one PRAME-targeting) as prior systemic treatment line, and thereof, six achieved a confirmed partial response, one a partial response and three stable disease. These results demonstrate anti-tumor activity of anzu-cel in patients who received prior TCR-based therapies.

Safety: Favorable tolerability in uveal melanoma, generally consistent with full anzu-cel tolerability profile

The most frequent treatment-emergent adverse events (TEAs) were anticipated cytopenias associated with lymphodepletion. Expected and manageable cytokine release syndrome (CRS) was mostly Grade 1 or 2, which is consistent with the mechanism of action (Grade 1: 37.5%, Grade 2: 43.8%, Grade 3: 18.8%, Grade 4: 0%). No patients experienced long-term CRS, and most CRS was resolved by day 14. No anzu-cel-related Grade 5 events were observed.

Tolerability in the uveal melanoma subset was generally consistent with the full anzu-cel tolerability profile in the Phase 1b.

Development Path for Anzu-cel in Metastatic Uveal Melanoma

Based on the promising clinical data in patients with metastatic uveal melanoma, Immatics has initiated a Phase 2 cohort with approximately 30 uveal melanoma patients planned. The cohort is being conducted at select centers in the U.S. and Germany with deep expertise in uveal melanoma. Given the high prevalence of PRAME expression in uveal melanoma, prospective PRAME testing is no longer required for inclusion in the clinical trial.

The consistent tolerability, anti-tumor activity and pharmacokinetic profile of anzu-cel across both uveal and cutaneous melanoma provide a strong rationale for pursuing a parallel late-stage development strategy to serve both patient populations.

About PRAME
PRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and a combination therapy that target PRAME: anzu-cel (IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific, anzu-cel in combination with Moderna’s PRAME cell therapy enhancer.

About Anzu-cel (IMA203) PRAME Cell Therapy
Anzu-cel (anzutresgene autoleucel; IMA203) is a PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. Anzu-cel PRAME cell therapy is currently being evaluated in a registration-enabling randomized controlled Phase 3 trial, "SUPRAME," in patients with unresectable or metastatic cutaneous melanoma who have disease progression on or after treatment with at least one checkpoint inhibitor. In parallel, the Phase 1b clinical trial in patients with PRAME cancers is ongoing with a focus on uveal melanoma.

(Press release, Immatics, OCT 20, 2025, View Source [SID1234656815])

On October 20, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported detailed results from STELLAR-303, a global phase 3 pivotal trial evaluating zanzalintinib in combination with atezolizumab (Tecentriq) versus regorafenib in patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer (CRC). As previously announced, the study met one of its dual primary endpoints, demonstrating a 20% reduction in the risk of death with the combination in the intention-to-treat (ITT) population at the final analysis (stratified hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.69-0.93; P=0.0045). At a median follow-up of 18.0 months, median overall survival (OS) in the ITT population was 10.9 months with zanzalintinib in combination with atezolizumab versus 9.4 months with regorafenib. Detailed findings from the study, including OS and progression-free survival (PFS) in the ITT population and in the subset of patients without liver metastases, are being presented today at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress during the Proffered Paper Session 2: GI Tumours, Lower Digestive at 9:25 a.m. CEST and simultaneously published in The Lancet.

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"While treating non-MSI-high metastatic colorectal cancer remains a challenge, the combination of zanzalintinib and atezolizumab has shown consistent benefits across key subgroups of patients," said Anwaar Saeed, M.D., Section Chief of Gastrointestinal Oncology at the University of Pittsburgh, Director of the Gastrointestinal Disease Center at UPMC Hillman Cancer Center and a lead investigator of the trial. "STELLAR-303 is the first immunotherapy-based phase 3 trial that demonstrated improved overall survival with a differentiated kinase inhibitor compared to a standard of care in this patient population. The survival benefit was demonstrated early and was consistent throughout the trial, underscoring the combination’s potential for patients in need of a new and effective treatment option after disease progression."

An OS benefit with the combination was consistently observed across pre-specified subgroups, including geographic region, RAS status, liver involvement and prior anti-VEGF therapy, as presented in Table 1 below. The 12- and 24-month landmark OS estimates were 46% (95% CI: 41-51) and 20% (95% CI: 15-26), respectively, for the combination of zanzalintinib and atezolizumab, and 38% (95% CI: 34-43) and 10% (95% CI: 6-16), respectively, for regorafenib.

TABLE 1

Median OS, months (95% CI)

HR (95% CI)

Zanzalintinib + Atezolizumab

Regorafenib

Geographic region

Asia

11.5 (9.2-13.7)

8.8 (7.8-10.4)

0.77 (0.59-1.00)

Rest of the world

10.9 (9.3-12.3)

9.8 (8.3-10.9)

0.82 (0.68-0.99)

RAS status

Wild type

12.0 (10.1-14.6)

10.4 (8.7-12.3)

0.79 (0.61-1.01)

Mutant

10.3 (9.0-11.9)

8.7 (8.1-9.8)

0.80 (0.66-0.98)

Active liver metastases

Presence

8.9 (8.0-9.9)

7.7 (6.5-8.5)

0.78 (0.65-0.94)

Absence

15.9 (13.5-17.6)

12.8 (10.9-15.5)

0.77 (0.59-1.01)

Prior anti-VEGF antibody treatment

Yes

10.6 (9.3-12.5)

8.8 (8.3-9.9)

0.80 (0.68-0.95)

No

11.5 (8.7-13.5)

11.1 (9.5-12.6)

0.80 (0.56-1.15)

OS = overall survival; CI = confidence interval; HR = hazard ratio; VEGF = vascular endothelial growth factor

Data pertaining to the other dual primary endpoint, OS in patients without liver metastases (non-liver metastases, NLM), were immature at the data cutoff. A prespecified interim analysis showed a trend in OS favoring the combination (15.9 months versus 12.8 months; stratified HR: 0.79; 95% CI: 0.61-1.03; P=0.0875) at a median follow-up of 16.8 months. The trial will proceed to the planned final analysis for this endpoint.

"These detailed results from STELLAR-303 provide further insight into the combination of zanzalintinib and atezolizumab as a potential new option to extend survival in patients with previously treated metastatic colorectal cancer," said Dana T. Aftab, Ph.D., Executive Vice President, Research and Development, Exelixis. "Before the end of this year, we intend to complete the submission of our first new drug application for zanzalintinib as we work toward bringing this combination regimen to a patient community seeking a new and chemotherapy-free option. These data, along with our robust clinical trial program, underscore the progress we are making toward our goal of increasing the scope and scale of the solid tumor types zanzalintinib may help address."

A trend for improvement in PFS with the combination was also observed in the ITT population (stratified HR: 0.68 [95% CI: 0.59–0.79]; median, 3.7 [95% CI: 3.5–3.8] months versus 2.0 [95% CI: 1.9–2.6] months), though statistical superiority cannot be claimed at this time due to the prespecified hierarchical testing strategy. The trend for PFS improvement with zanzalintinib in combination with atezolizumab versus regorafenib was consistent across subgroups.

The safety profiles of zanzalintinib in combination with atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified. Grade 3/4 treatment-related adverse events (AEs) occurred in 59% of patients receiving zanzalintinib in combination with atezolizumab and 37% of patients receiving regorafenib. AEs leading to discontinuation of all study treatment occurred in 18% versus 15% of patients, respectively. The most common grade 3/4 treatment-related AEs were hypertension (15% versus 9%, respectively), fatigue (6% versus 2%), diarrhea (6% versus 2%) and proteinuria (6% versus 2%). Deaths considered related to treatment by investigators were two for zanzalintinib, two for atezolizumab, one for the combination and one for regorafenib.

About STELLAR-303
STELLAR-303 (NCT05425940) is a global, multicenter, randomized, phase 3, open-label study that randomized patients 1:1 to either zanzalintinib in combination with atezolizumab (n=451) or regorafenib (n=450). The study includes patients with previously treated non-MSI-high metastatic CRC. The dual primary endpoints of the study are OS in the ITT population and in the NLM subgroup of patients. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Secondary endpoints include PFS, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. More information about the trial is available at ClinicalTrials.gov.

About Zanzalintinib
Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. With zanzalintinib, Exelixis sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including colorectal cancer, kidney cancer and neuroendocrine tumors.

Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials.

About CRC
CRC is the third most common cancer and the second leading cause of cancer-related deaths in the U.S.1 Approximately 154,000 new cases will be diagnosed in the U.S. with around 53,000 expected deaths from the disease in 2025.1 CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.2 Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is just 16.2%.2 The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.

(Press release, Exelixis, OCT 20, 2025, View Source [SID1234656814])

On October 20, 2025 Disc Medicine, Inc. (NASDAQ: IRON) (Disc), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported the commencement of an underwritten offering of $220.0 million of shares of its common stock and, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock, of which $200.0 million of shares are to be offered by Disc and $20.0 million of shares are to be offered by AI DMI LLC (the Selling Stockholder). In addition, the Selling Stockholder intends to grant the underwriters a 30-day option to purchase up to an additional $33.0 million of shares at the public offering price, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Disc intends to use the net proceeds from the proposed offering to support the potential commercialization of bitopertin for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), to fund research and clinical development of its current or additional product candidates, and for working capital and other general corporate purposes. Disc will not receive any proceeds from the sale of shares to be offered by the Selling Stockholder.

Jefferies, Leerink Partners, Morgan Stanley and Cantor are acting as joint book-running managers for the proposed offering.

The proposed offering is being made pursuant to an automatic shelf registration statement on Form S-3 (No. 333-281359) that was previously filed with the Securities and Exchange Commission (SEC) on August 8, 2024 and a resale registration statement on Form S-3 (No. 333-269270) that was previously filed with the SEC on January 18, 2023. This proposed offering is being made only by means of a prospectus supplement and accompanying prospectuses that form a part of the registration statements. A preliminary prospectus supplement and accompanying prospectuses related to the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectuses relating to this proposed offering may also be obtained, when available, by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, (800) 808-7525 ext. 6105 or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York, 10022, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

(Press release, Disc Medicine, OCT 20, 2025, View Source [SID1234656813])

On October 20, 2025 Arvinas, Inc. (Nasdaq: ARVN), reported new patient-reported outcomes (PRO) data from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant, which are being presented in a mini oral session at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. Vepdegestrant is a novel investigational PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader which is being developed with Pfizer Inc. (NYSE: PFE) as a potential monotherapy for estrogen receptor 1 (ESR1) mutated, estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine-based therapy.

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In the VERITAC-2 clinical trial, patients with ESR1-mutated disease treated with vepdegestrant reported a statistically significant delay in deterioration of overall quality of life, pain, and multiple functioning domains compared to those who received fulvestrant. These findings complement previously reported clinical efficacy and safety data from the VERITAC-2 clinical trial, reinforcing vepdegestrant as a potential treatment option for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy.

"These new data highlight the potential of vepdegestrant to provide significant improvements across important measures for patients with ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second-line setting," said John Houston, Ph.D., Chairperson, President and Chief Executive Officer of Arvinas. "In addition to a statistically significant improvement in progression-free survival, patients receiving vepdegestrant had statistically significant and clinically meaningful benefits in patient-reported outcomes as compared to fulvestrant while being treated for their cancer. These data from the VERITAC-2 clinical trial reflect Arvinas’ goal of striving to pair scientific innovation with improved patient outcomes."

In patients with ESR1-mutated disease, vepdegestrant demonstrated a reduced risk of deterioration compared to fulvestrant which was statistically significant in several PRO domains including overall health status, pain severity, and functioning (including role, cognitive, emotional, and social functioning), and vepdegestrant consistently showed reduced risk of deterioration versus fulvestrant across all PRO domains.

We believe these data support vepdegestrant’s opportunity to be a potential best-in-class therapy for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine therapy.

Also presented at ESMO (Free ESMO Whitepaper) 2025 were results from the TACTIVE-N Phase 2 clinical trial (NCT05549505), which evaluated neoadjuvant vepdegestrant in postmenopausal women with ER+/HER2– localized breast cancer. The results presented showed that neoadjuvant vepdegestrant demonstrated biological and clinical activity in this treatment-naïve, predominantly ESR1 wild-type population of postmenopausal women with ER+/HER2- localized breast cancer.

Additional detail on Arvinas and Pfizer’s presentations at ESMO (Free ESMO Whitepaper) 2025:

Title: Patient-reported outcomes (PROs) with vepdegestrant (VEP) vs fulvestrant (FUL) in patients (pts) with estrogen receptor (ER) 1 gene mutated (ESR1m) ER+/human epidermal growth factor receptor 2 (HER2)− advanced breast cancer (aBC) in the phase 3 VERITAC-2 trial
Presenting Author: Dr. Mario Campone
Presentation Number: 489 MO
Presentation Type: Mini oral session
Session: Breast cancer, metastatic
Date: October 20, 2025
Time: 11:25-11:30 AM CEST

Title: TACTIVE-N: phase 2 study of neoadjuvant vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, or anastrozole in postmenopausal ER+/human epidermal growth factor receptor 2 (HER2)- localized breast cancer (BC)
Presenting Author: Dr. Peter A. Fasching
Presentation Number: 293MO
Presentation Type: Mini oral session
Session: Breast cancer, early stage
Date: Sunday, October 19, 2025
Time: 10:45-10:50 AM CEST

About the VERITAC-2 Clinical Trial

The Phase 3 VERITAC-2 clinical trial (NCT05654623) is a global, randomized trial evaluating the efficacy and safety of vepdegestrant (ARV-471) as a monotherapy compared to fulvestrant in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with a CDK4/6 inhibitor plus endocrine therapy. The trial enrolled 624 patients, 270 of whom had ESR1m positive disease, at 213 sites in 25 countries.

Patients were randomized 1:1 to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2. In the trial, 43% of patients (n=270) had ESR1 mutations detected. The primary endpoint was progression-free survival (PFS) in the ESR1-mutation and intent-to-treat populations as determined by blinded independent central review. Overall survival is the key secondary endpoint.

About Vepdegestrant

Vepdegestrant is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) estrogen receptor degrader. Vepdegestrant is being developed as a potential monotherapy for estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the out-licensing and commercialization of vepdegestrant.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant for its use as a monotherapy in the treatment of adults with ER+/HER2- ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. Vepdegestrant has also been granted Fast Track designation by the FDA, underscoring the significant unmet need in this patient population and the potential for vepdegestrant to offer a meaningful new treatment option.

(Press release, Arvinas, OCT 20, 2025, View Source [SID1234656811])

On October 20, 2025 Archivel Farma reported the outcome of RUTIVAC study in Bladder Cancer.

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The RUTI vaccine, developed and produced in-house by Archivel Farma, was tested in a phase I trial involving 40 patients with high-risk non-muscle-invasive bladder cancer at Hospital Universitari Germans Trias i Pujol. Administered prior to standard BCG therapy, RUTI enhanced the immune response, reducing tumor recurrence and progression, and improving patient survival over five years.

The vaccine generated stronger CD4⁺ and CD8⁺ T-cell responses and increased cytokine production, without promoting immunosuppressive T-regulatory cells. Importantly, RUTI was well tolerated with only mild injection-site reactions.
These promising results, published in European Urology, suggest that RUTI could enhance the current standard of care for bladder cancer, paving the way for larger trials to confirm its clinical benefits. Read in View Source

Archivel Farma has been both, sponsor and RUTI supplier for this study. We extend our sincere thanks and congratulations to our partners, IrsiCaixa and the Germans Trias i Pujol Research Institute (IGTP), for their dedication and excellent work.

(Press release, Archivel Farma, OCT 20, 2025, View Source [SID1234656810])